Quality Technical Manager Sterile Injectables Wrexham

Permanent Full Time

Hybrid Office 3 days P/W WFH 2

Our client is a market leader in the sales and distribution of generic injectables. These are sold into NHS hospitals and private clinics via a pharmaceutical wholesaler in the UK. My client prides themselves on customer service and ensuring that every client gets the stock they need to care for their patients. They hold an unrivalled amount of stock of injectables to ensure quick and safe delivery.

Tasks

Due to an upcoming retirement of a long standing and expert employee they are now seeking an experienced Quality & Technical Manager to be the Responsible Person (RPi) on a wholesale Dealer Authorisation. Reporting to the Managing Director as The Quality and Technical Manager you will: Act as the Quality Management System Administrator and perform all associated duties.

• Manage and undertake the administration of quality complaints.
• Preparing management documentation
• Preparation and update of SOPs
• Manage Medical Information Service provider & respond to MI enquiries where required.
• Preparation management and review of technical agreements and safety data exchange (PV) agreements
• Liaise with Marketing Authorisation holders with respect to pharmacovigilance responsibilities.
• Reporting of Medical Information and PV data to MA holders
• RPi duties for the Company & deputy Consultant RPi as required.
• Supplier routine audits & audits for cause with consultant QP/RPi
• Annual Staff Training for PV & GDP

Requirements

The ideal Technical & Quality Manager will already have:

• Minimum of 5 years experience in a pharmaceutical environment managing QMS compliance in a cGMP/GDP environment
• Must have sterile injectables Quality Management Systems/Quality Assurance/Medical Information/Pharmacovigilance experience either from Vaccines manufacturing Covid19 vaccine manufacturing generic injectables or pharmaceutical vaccine distribution sterile injectables sales and distribution companies such as Botox/injectable fillers
• Must have a science degree or equivalent.
• Must have the qualifications/experience to be an RPi on a wholesale dealer authorisation.
• Ability to travel infrequently (once or twice a year to European suppliers sites) and to suppliers sites in the UK less than 10%

Benefits

The role is hybrid 3 days per week from Wrexham and the other two days working from home.

You will need your own car and full clean driving licence to travel to and from the office. Free parking is available on site.

Please apply by calling Emma Howarth MD of Langton Howarth STEM Consultants on 0 right now. Immediate interviews and start date are available.